MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. CONTOUR NEXT; BLOOD GLUCOSE TEST STRIPS

Model Number	7311
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.No information was captured, as the customer's weight was not provided.
Event or Problem Description
The customer reported that she obtained a blood glucose reading of 331 mg/dl at 7:38 a.M.On the contour next one meter.Within 10 minutes, another blood test was performed with an alternate meter and a reading of 144 mg/dl was obtained.There was no allegation of an adverse event.The customer was advised to return the device for evaluation.Replacement meter kit and test strips were sent to the customer.
Additional Manufacturer Narrative
The customer did not return the suspected contour next one meter for evaluation.Therefore, a device history record was reviewed for the suspected meter and no manufacturing anomalies were found.

• Brand Name: CONTOUR NEXT
• Common Device Name: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): ASCENSIA DIABETES CARE US INC.; 100 summit lake drive; valhalla NY 10595
• MDR Report Key: 10680238
• Report Number: 1810909-2020-00545
• Device Sequence Number: 1257767
• Product Code: NBW
• UDI-Device Identifier: 10301937311502
• UDI-Public: 10301937311502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Model Number: 7311
• Device Catalogue Number: 7311
• Device Lot Number: 9GPEG09A
• Initial Date Received by Manufacturer: 09/20/2020
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR